IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Methadone

Criteria

Inclusion Criteria:

• Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,

• Age 12 - 19 inclusive

• ASA class I-II.

Exclusion Criteria:

• Preoperative opioid therapy in previous 2 weeks

• Known hepatic or renal impairment

• Inability to assess pain score due to neurological impairment, hearing impairment

• Allergy to methadone, morphine, fentanyl, propofol or remifentanil

• Pregnant or nursing

• Taking SSRI's, MAOI,anticonvulsants, gabapentin or lyrica

• ASA III or greater patients are excluded

• pre-existing chronic pain